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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Programmer, Changer, Film/Cassette, Radiographic
510(k) Number K854251
Device Name THE CSE FILM CHANGER SYSTEM
Applicant
Changer Service & Engineering, Inc.
7832 Alabama St., Unit 7
Canoga Park,  CA  91304
Applicant Contact LEIF JOHANSSON
Correspondent
Changer Service & Engineering, Inc.
7832 Alabama St., Unit 7
Canoga Park,  CA  91304
Correspondent Contact LEIF JOHANSSON
Regulation Number892.1870
Classification Product Code
IZP  
Date Received10/22/1985
Decision Date 10/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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